Electrical Muscle Stimulation With 1064 nm Diode Laser and RF/PEMF for Non-invasive Body Contouring and Fat Reduction.

Muscle Tone Increased Clinical Trial

Official title: Safety and Efficacy of Electrical Muscle Stimulation Combined With 1064 nm Diode Laser, Pulsed Electromagnetic Field (PEMF) and Vacuum Assisted Radio Frequency (RF) for Non-invasive Body Contouring and Fat Reduction.

Status Active, not recruiting

Clinical Trial Summary

Multi-center, three-arm, randomized, evaluator-blinded study of electrical muscle stimulation (EMS) and/or 1064 nm diode laser, pulsed electromagnetic field (PEMF) and vacuum assisted radio frequency (RF) using the Venus Bliss Max for fat reduction, body contouring and aesthetic improvement.

Clinical Trial Description

The study will enroll up to 60 male and female subjects, ≥ 18 years of age, requesting non-invasive electrical muscle stimulation (EMS) and/or lipolysis of the abdomen and flanks. Subjects will be randomized to one of three arms as per randomization scheme.

This study will have 3 Arms at a ratio of 2:1:1 (A:B:C):

Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF) Arm B: EMS/RF Arm (EMS + RF/PEMF) Arm C:

EMS Arm (EMS only)

Arm A: Three (3) diode laser treatments treatments at days 0, 28 and 56 (±2 days). Subjects will also receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields (PEMF)/vacuum assisted radio frequency (RF) treatments at days 0, 14, 28, 42 and 56 (±2 days).

Arm B: Subjects will receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields/vacuum assisted radio frequency treatments at days 0, 14, 28, 42 and 56 (±2 days).

Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days).

Subjects in Arms A and B will be followed at 84 and 140 days (±7 days) after their last treatment. Subjects in Arm C will be followed at 63 and 119 days (±7 days) after their last treatment. ;

Related Conditions & MeSH terms

• Fat Reduction
• Muscle Hypertonia
• Muscle Tone Increased

• NCT number: NCT05256771
• Study type: Interventional
• Source: Venus Concept
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Completion date: March 31, 2025